BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3780899 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11784
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/20/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/14/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT THERE WAS NO EVIDENCE OF A LOAD STEP MALFUNCTION RECORDED. THE PUMP WAS NOT ABLE TO COMPLETE THE REWIND STEP DUE TO A CALL SERVICE ALARM. THE COMPLAINT OF THE LOAD STEP MALFUNCTION WAS NOT ABLE TO BE INVESTIGATED DUE TO THE CALL SERVICE ALARM ISSUE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. IT WAS REPORTED THAT THE PUMP HAD PRIMED THE TUBING DURING THE LOAD STEP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260929 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR